Duns Number:813116209
Device Description: The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities.
Catalog Number
VP40002401
Brand Name
V-PRO
Version/Model Number
V-PRO 60
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140498,K162413,K172319,K182568,K190917,K222849
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
90bd2953-b32c-490f-b0c7-d1a6ade9f9f1
Public Version Date
October 27, 2022
Public Version Number
2
DI Record Publish Date
April 16, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 548 |